A Phase 2 interventional study of Proton Radiation and Capecitabine in Pancreatic Cancer, sponsored by Proton Collaborative Group. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Proton Collaborative Group · Phase 2, Interventional, and Treatment
The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days.
In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.
Required pretreatment laboratory parameters:
Exclusion Criteria:
The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.
Radiation: Proton Radiation · Drug: Capecitabine · Procedure: Surgical resection
Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
Also known as: Proton Beam Radiation
Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Also known as: Xeloda
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.
Overall survival at 12 months after radiation therapy
The trial is designed to allow detection of an improvement in the 12 month overall survival rate to 75% compared to the expected historical rate of 50%.
Time frame: Approximately 12 months after radiation therapy.
Surgical resection rate.
Increase share of marginally resectable and unresectable patients being converted to resectable.
Time frame: 3 months following the completion of radiation therapy.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Proton Collaborative Group